FDA 510(k) clearances — page 819
clearances on record, most recent first.
Clearances — page 819
81,801–81,900 of 175,825- K002647 — MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
- K002682 — MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K002701 — POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
- K992476 — PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
- K993773 — HUMID-HEAT
- K994137 — ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE
- K001642 — INSIGHT IMAGE GUIDED SURGICAL SYSTEM
- K001800 — ACCUWARM EMG HEAT LAMP
- K001806 — REFRACTIVE SURGERY BLADES
- K002044 — MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
- K002517 — USS VAS
- K002559 — EL-ANA PROFILES-2K1
- K002607 — MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
- K991502 — MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
- K001461 — TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
- K001784 — VIRIDIS LASER
- K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
- K002032 — C02 LASER MULTIPULSE
- K002040 — FMS SOLO
- K002072 — PROLITE VL PULSED LIGHT SYSTEM
- K002416 — GOLDEN-RULE SCALING CATHETER
- K002448 — LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
- K002511 — FETALTROL
- K002722 — DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
- K002739 — INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
- K000599 — VITALOGRAPH BASE STATION
- K000705 — RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
- K001725 — HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
- K001766 — OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
- K001951 — PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
- K001995 — SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
- K002096 — TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
- K002111 — RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
- K002299 — SUPER 3
- K002301 — SUPER 12
- K002465 — SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
- K002470 — M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
- K002477 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K002579 — DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)
- K000643 — INPLANT ORTHODONTIC ANCHOR SYSTEM
- K000830 — CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
- K000997 — ZORTRAN DETECTOR
- K001342 — P.O.P. PAIN KIT
- K001765 — LOOK COLLAGEN SPACERS, MODEL 1514B
- K001872 — I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
- K002060 — NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
- K000743 — BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
- K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
- K001796 — GYROSCAN INTERA (R7.5)
- K001987 — EXPLORER GRADIENT
- K002001 — BREEZE SLEEPGEAR WITH DREAMSEAL
- K002016 — PHILIPS INTEGRIS ALLURA
- K002026 — CAPIOX ARTERIAL FILTER
- K002158 — S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
- K002574 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
- K002655 — DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
- K994349 — COAGUCHEK S SYSTEM, MODEL 2138280
- K001907 — CAMIT DIABETES MANAGEMENT SOFTWARE
- K002051 — INVIDOS
- K002165 — LINEZOLID, 30UG, BBL SENSI-DISC
- K002380 — INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
- K002602 — OBC-63 MEBREAST ARRAY COIL
- K002609 — TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K993675 — PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
- K994103 — OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT
- K002432 — STRATO X
- K002441 — FENNING HIP STEM
- K002508 — EQUIPMENT DRAPES
- K000517 — LIFE SCOPE EC, MODEL BSM-1102
- K000700 — SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
- K000919 — 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
- K001134 — GAZELLE BALLOON DILATATION CATHETER
- K001579 — IMPULSE SELECT
- K001704 — ATHOS
- K001709 — TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
- K001712 — 3D ACTIVETRAC
- K001760 — RADIOLUCENT COLLES FRACTURE KIT
- K001898 — VASOTRAX
- K002109 — OLEEVA FOAM
- K002149 — LINEAGE ACETABULAR SYSTEM
- K002222 — RD-2104
- K002333 — BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
- K002379 — M2A 28MM RINGLOC LINER
- K002402 — VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
- K002422 — VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
- K002453 — ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
- K002460 — LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
- K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
- K991864 — ROTAFLOW CENTRIFUGAL PUMP SYSTEM
- K994022 — PARALLAX CRANIOSET
- K994041 — TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
- K000251 — SPECTRUM SILICONE FOLEY CATHETER
- K001052 — MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
- K001127 — ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
- K001300 — D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
- K001338 — MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
- K001420 — SLIDESCAN
- K001818 — UTERINE TENACLUM HOOK
- K001946 — NEUROVASCULAR ARRAY COIL
- K002048 — JBC OPAQUE AND GLITTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.